ASTM F3374-19
(Guide)Standard Guide for Active Fixation Durability of Endovascular Prostheses
Standard Guide for Active Fixation Durability of Endovascular Prostheses
SIGNIFICANCE AND USE
5.1 Once implanted, active fixation systems are subjected to cyclic loading that can be caused by blood flow, musculoskeletal motion, and other sources. The focus of this document is on axial loading caused by hemodynamics. However, depending on the device design other loading modes could influence AFC or attachment mechanism durability (e.g., radial dilatation could lead to longitudinal foreshortening and axial loading on an active fixation system). Damage to AFCs and/or attachment mechanisms may not necessarily lead to device malfunction, but could cause embolization of portions of the device, device migration, endoleaks, or other patient complications (1-4).4 Therefore, durability testing of AFCs and attachment mechanisms is important to ensure that these components are capable of maintaining structural integrity for a defined lifetime.
5.1.1 A test method developed following this standard guide can be used to determine the durability of AFCs and/or attachment mechanisms under the desired loading which can be used to assess conformance to product specifications, consensus standards, and guidance documents as well as to support regulatory submissions, quality control, and manufacturing.
5.2 This guide provides examples and recommendations so that users can develop an appropriate active fixation durability test for their device design that mechanically challenges either the AFC, the attachment mechanism, or both simultaneously. It should be recognized that both AFCs and attachment mechanisms need to be evaluated to fully characterize active fixation system durability for design verification testing. While testing of the entire active fixation system may typically be preferable, this guide recognizes that there might be situations where this is not practical or desired and allows for independent testing of AFCs and attachment mechanisms. This guide does not contain an exhaustive list of test methods for active fixation durability and methods not included herei...
SCOPE
1.1 This guide addresses how to conduct in vitro durability testing on active fixation components (AFCs) and attachment mechanisms of endovascular prostheses. It does not address the durability of fixation systems that reside solely within the vessel lumen to resist device migration (e.g, radial force and friction, adhesives, or geometric fit).
1.2 This guide was developed to address active fixation durability for aortic stent grafts. It is not intended to address fixation durability for other endovascular prostheses such as inferior vena cava filters, transcatheter heart valves, barbed venous stents, ancillary fixation devices (e.g, staples or adhesives), or cardiac devices (e.g., left atrial appendage device or mitral repair device). However, some of the techniques and guidance within may be applicable to the in vitro testing of those other devices.
1.3 This guide does not directly apply to implants with absorbable AFCs although many aspects of this standard are applicable to those products.
1.4 This guide does not provide the in vivo physiologic loading conditions for endovascular prostheses. It is the responsibility of the user to determine the loading or deformation conditions for their particular device and indication. Typically, an axial loading (force or displacement) mode caused by hemodynamics is used, although other modes are possible and should be considered.
1.5 This guide does not recommend any specific test method or apparatus for evaluating active fixation durability. It is recognized that there are multiple valid ways to conduct active fixation durability testing and as such this guide provides general recommendations and topics to consider so that users can successfully develop a test plan for their device.
1.6 Units—The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.7 This standard does not purport to address al...
General Information
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Standards Content (Sample)
This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Designation: F3374 − 19
Standard Guide for
1
Active Fixation Durability of Endovascular Prostheses
This standard is issued under the fixed designation F3374; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope 1.7 This standard does not purport to address all of the
safety concerns, if any, associated with its use. It is the
1.1 This guide addresses how to conduct in vitro durability
responsibility of the user of this standard to establish appro-
testing on active fixation components (AFCs) and attachment
priate safety, health, and environmental practices and deter-
mechanismsofendovascularprostheses.Itdoesnotaddressthe
mine the applicability of regulatory limitations prior to use.
durability of fixation systems that reside solely within the
1.8 This international standard was developed in accor-
vessel lumen to resist device migration (e.g, radial force and
dance with internationally recognized principles on standard-
friction, adhesives, or geometric fit).
ization established in the Decision on Principles for the
1.2 This guide was developed to address active fixation
Development of International Standards, Guides and Recom-
durability for aortic stent grafts. It is not intended to address mendations issued by the World Trade Organization Technical
fixation durability for other endovascular prostheses such as
Barriers to Trade (TBT) Committee.
inferior vena cava filters, transcatheter heart valves, barbed
venous stents, ancillary fixation devices (e.g, staples or
2. Referenced Documents
adhesives), or cardiac devices (e.g., left atrial appendage
2
2.1 ASTM Standards:
device or mitral repair device). However, some of the tech-
E739 PracticeforStatisticalAnalysisofLinearorLinearized
niques and guidance within may be applicable to the in vitro
Stress-Life (S-N) and Strain-Life (ε-N) Fatigue Data
testing of those other devices.
F2477 Test Methods forin vitro Pulsatile Durability Testing
of Vascular Stents
1.3 This guide does not directly apply to implants with
absorbable AFCs although many aspects of this standard are F2942 Guide forin vitro Axial, Bending, and Torsional
Durability Testing of Vascular Stents
applicable to those products.
F3172 Guide for Design Verification Device Size and
1.4 This guide does not provide the in vivo physiologic
Sample Size Selection for Endovascular Devices
loading conditions for endovascular prostheses. It is the re-
F3211 Guide for Fatigue-to-Fracture (FtF) Methodology for
sponsibilityoftheusertodeterminetheloadingordeformation
Cardiovascular Medical Devices
conditions for their particular device and indication. Typically,
3
2.2 Other Documents:
an axial loading (force or displacement) mode caused by
ASMEV&V40 Assessing Credibility of Computational
hemodynamics is used, although other modes are possible and
Modeling and Simulation Results throughVerification and
should be considered.
Validation: Application to Medical Devices
1.5 Thisguidedoesnotrecommendanyspecifictestmethod
ISO 25539 Cardiovascular implants – Endovascular devices
or apparatus for evaluating active fixation durability. It is
– Part 1: Endovascular prostheses
recognized that there are multiple valid ways to conduct active
fixation durability testing and as such this guide provides
3. Terminology
general recommendations and topics to consider so that users
3.1 Definitions:
can successfully develop a test plan for their device.
3.1.1 endovascular prosthesis, n—vascular prosthesis (in-
1.6 Units—The values stated in SI units are to be regarded
cluding modular components) which resides partially or com-
as standard. No other units of measurement are included in this
pletely within a blood vessel, or vascular conduit to form an
standard.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
1
This guide is under the jurisdiction of ASTM Committee F04 on Medical and contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Surgical Materials and Devices and is the direct responsibility of Subcommittee Standards volume information, refer to the standard’s Document Summary page on
F04.30 on Cardiovascular Standards. the ASTM website.
3
Current edition approved June 1, 2019. Published July 2019. DOI: 10.1520/ Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
F3374-19. 4th Floor, New York, NY 10036, http://www.ansi.org.
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